Kornimate/medical-research-clean huggingface dataset:
a study comparing haploidentical hematopoietic stem cell transplantations (hscts) from young non-first-degree and older first-degree donors in hematological malignancies

Conditions: Leukemia

Summary: an open, multi-center, randomized trial comparing haploidentical hscts from young non-first-degree and older first-degree donors in hematological malignancies

this is an open, multi-center, randomized trial comparing the clinical outcomes of haploidentical hscts from young non-first-degree and older first-degree donors in hematological malignancies. this study is indicated for patients with hematological malignancies including acute leukemias and mds who are eligible to haploidentical hscts. 2 groups of patients will be enrolled with 88 in each group. the clinical criteria including survival, relapse, transplantation-related mortality will be monitored.

Eligibility criteria:
patient inclusion criteria: * patient age 13-78 years * absence of a suitable hla identical related or unrelated hematopoietic stem cell donor * absence of a suitable partially hla-mismatched (haploidentical), first-degree related donor aged between 18 and 50 * presence of both hla haploidentical young non-first-degree (age ≤ 40) and older first-degree (age \>50) donors eligible diagnoses: aml（excluding apl） with at least one of the following: * median- or high- risk according to the who prognostic stratification system * failure to achieve cr after 2 cycles of induction chemotherapy * aml arising from mds or a myeloproliferative disorder, or secondary aml * patients in cr2 or beyond mixed-phenotype acute leukemia (mpal) in morphological remission acute lymphoblastic leukemia (t or b) in morphological remission mds with at least one of the following: * ipss score of int-2 or greater * ipss score of int-1 with life-threatening cytopenias, including those generally requiring greater than weekly transfusions * a first allo-hct * adequate end-organ function * ecog performance status \< 2 * no other contraindications for hsct * signature of the informed consent patient exclusion criteria * availability of suitable hla identical related or unrelated hematopoietic stem cell donors * availability of suitable partially hla-mismatched (haploidentical), first-degree related donor aged between 18 and 50 * not the first allo-hct * presence of uncontrolled bacterial, viral, or fungal infection * patients with severe heart, lung, liver and kidney insufficiency * hiv-positive patients * women of childbearing potential who are pregnant (β-hcg+) or breast feeding * patients with a psychiatric history * ecog performance status ≥ 3 * patients with malignancies other than the primary disease * refusal to sign the informed consent donor inclusion criteria: * the donor and recipient must be hla haploidentical * meets institutional selection criteria and medically fit to donate * lack of recipient anti-donor hla antibody donor exclusion criteria: * the donor and recipient are hla identical * has not donated blood products to recipient

Keywords: hematopoietic stem cell transplantation
observational study of bone complications in people with post-menopausal breast cancer who have stopped treatment with denosumab and aromatase inhibitors

Conditions: Breast Cancer

Summary: the purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/ai and denosumab. the study team will collect information from 5 standard clinic visits over the course of 24 months. the information will include information about participant health assessments, blood test results, and imaging results. after 24 months, participation in this study will be complete.


Eligibility criteria:
inclusion criteria: * women with confirmed diagnosis of breast cancer * participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment * received at least 2 doses of denosumab and then discontinued therapy * discontinued ai prior to or within 6 months of last denosumab injection * patients must be 18 years of age or olde exclusion criteria: * patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy x-ray absorptiometry (dexa) scan; * patients with history of insufficiency fracture. * patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab * patients on chronic low-dose glucosteroids.

Keywords: post-menopausal breast cancer breast cancer denosumab aromatase 22-280 memorial sloan kettering cancer center
neonatal sleep intervention to improve postpartum hypertension

Conditions: Pre-Eclampsia; Gestational Hypertension; Sleep

Summary: the investigators are conducting a single center, randomized controlled trial testing the impact of a neonatal sleep intervention, the snoo, on reducing maternal blood pressure (bp) in the postpartum period in women with hypertensive disorders of pregnancy. the snoo is a responsive bassinet designed to automatically calm and consolidate infants by responding to their cries. use of the snoo has been demonstrated to improve infant sleep by 1-2 hours nightly, thus increasing maternal sleep time. the investigators plan for 110 women with pregnancies complicated by gestational hypertension or pre-eclampsia to be randomized 1:1 to either receive and use the snoo responsive bassinet for their infants, or to receive the usual care of safe sleep education. women will be followed longitudinally through 6 months postpartum with serial bps, weights, mood assessments, and subjective and objective sleep assessments. the investigators hypothesize that for women with pregnancies complicated by gestational hypertension or preeclampsia, that poor maternal sleep quality contributes to increased bp in the postpartum period. the investigators further propose that compared to usual care (safe sleep education), an intervention targeted to improve neonatal sleep (the snoo), and thus maternal sleep, will improve postpartum bp for these women.


Eligibility criteria:
inclusion criteria: * ≥18 years old * have a singleton, full-term (37 or greater weeks of gestation), live birth of a non-anomalous fetus * diagnosis of gestational hypertension or pre-eclampsia by american college of obstetricians and gynecologists criteria * enrolled in the institution's postpartum blood pressure remote monitoring program * willing to undergo randomization * willing to use the snoo for their neonate in the postpartum period if randomized to that study arm exclusion criteria: * \<18 years old * non-english speaking * diagnosis of chronic hypertension * diagnosis of pre-gestational diabetes * diagnosis of cardiac disease * diagnosis of kidney disease * diagnosis of liver disease * infant admitted to the neonatal intensive care unit * intend to use the snoo prior to study enrollment * not willing to be randomized * not willing to use the snoo if randomized to that study arm

Keywords: pre-eclampsia gestational hypertension postpartum sleep snoo
pipac and folfox for gastric cancer peritoneal cancer

Conditions: Gastric Cancer; Peritoneal Carcinomatosis

Summary: peritoneum is among the most common sites of metastases in gastric cancer. systemic chemotherapy is the current standard for peritoneal carcinomatosis (pc), although, the treatment results remain extremely poor. pressurized intraperitoneal aerosol chemotherapy (pipac) is a modern treatment modality for pc, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. despite some encouraging preliminary results for pipac efficacy, it is still an investigational treatment. furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and pipac. thus, this study will investigate the feasibility of pipac and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.

this open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in lithuania and will include 37 participants. gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and pipac with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. after the 3rd pipac procedure patients will be re-assessed and discussed at multidisciplinary team meetings. in case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. all patients will be followed up for 24 months.

Eligibility criteria:
inclusion criteria: 1. histologically verified gastric adenocarcinoma (her2 negative) with peritoneal carcinomatosis; 2. age≥18; 3. ecog≤1; 4. patient willing to participate; 5. patient is the candidate for 1st line folfox palliative systemic chemotherapy. exclusion criteria: 1. extra-abdominal metastases; 2. siewert i type gastroesophageal junction cancer; 3. mechanical bowel obstruction; 4. allergy to study drugs; 5. history of previous intraperitoneal chemotherapy; 6. pregnancy of refusal for birth-control at least 6 months post-study treatment

Keywords: gastric cancer peritoneal carcinomatosis pipac folfox bidirectional
proton radiation for chordomas and chondrosarcomas

Conditions: Chordomas; Chondrosarcomas

Summary: the objectives of this study are 1) to evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) to evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.

this trial will be conducted in two phases: a feasibility then a phase ii trial. once feasibility and safety are established in the first 12 pts. the phase ii study will begin. proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of chordoma or chondrosarcoma. * patients must have no evidence of metastatic disease based on routine imaging (ct or mri of the chest/abdomen/pelvis, bone scan, etc.) * patients must have an ecog score equal to or less than 2. * age ≥ 18 years. * patients must be able to provide informed consent. * adequate bone marrow function: wbc ≥ 4000/mm3, platelets ≥ 100, 000mm3 * women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , iud, condoms or other barrier methods etc.) hysterectomy or menopause must be clinically documented. * tumors arising in the skull and spine. exclusion criteria: * prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies. * pregnant women. * actively being treated on any other therapeutic research study. * tumors arising outside of the cns.

Keywords: age 18 or greater no prior radiation
a phase 1 study of air645 in healthy subjects and subjects with controlled asthma

Conditions: Asthma

Summary: this is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized air645.


Eligibility criteria:
inclusion criteria\*: * good general health (with or without allergic rhinitis and/or controlled asthma) * non-smoker for at least 2 years * normal lung function (dlco) * able to provide informed consent and to understand and comply with the requirements of the study exclusion criteria\*: * clinically significant medical history or condition which precludes participation * clinically significant ecg abnormality * clinically significant vs or pe abnormality * clinically significant screening lab abnormality * abnormal lung function (fev1 \<80% predicted) * respiratory infection within 14 days of randomization * hbv, hcv, or hiv * breastfeeding or pregnant female * history of alcohol abuse or illicit drug use within past 24 months * use of any tobacco or nicotine-containing product within past 6 months * use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol * use of any investigational drug within past 30 days * use of any investigational monoclonal antibody or recombinant protein within past 90 days * donation of plasma within past 7 days * donation or loss of whole blood within past 56 days * simplified list of i/e criteria; unabridged list available upon request.

Keywords: air645 altair therapeutics il4 il13 il-4 il-13
clinical validation of the rating scale for psychotic depression (ras-pd)

Conditions: Affective Disorders, Psychotic

Summary: the aim of this study is to develop a scale to measure the severity of depression with psychotic symptoms (psychotic depression). furthermore, we hope to detect potential biomarkers (substances in the blood) which can aid in the detection of psychotic depression. main hypothesis: a clinically valid rating scale measuring the severity of psychotic depression can be developed.


Eligibility criteria:
inclusion criteria: * fulfilling icd-10 criteria df32.3 or df33.3 * at least 18 years old * legally competent * informed consent (oral \& written) exclusion criteria: * insufficient danish language skills * moderate to severe dementia * abuse of psychoactive substances

Keywords: affective disorders, psychotic psychometrics biological markers
integrated molecular and clinical profiling to improve disease characterization and outcome prediction in nodal marginal zone lymphoma

Conditions: Nodal Marginal Zone Lymphoma

Summary: international retrospective observational cohort study aimed to describe a molecular classification for nmzl.

already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. each patient enrolled in the study will be assigned to a unique identification numerical code upon registration in the study. the unique identification code will be used to record health-related data and to label biological samples. the coded biological material will be transferred to the coordinating center at the oncology institute of southern switzerland and institute of oncology research in bellinzona. health-related data will be collected in the ecrf (openclinica). data quality will be insured by query generation. annotated baseline features will include date of diagnosis, date of lymph node biopsy, age, gender, ecog ps, ann arbor stage, ldh, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, number of nodal sites, b symptoms, lymph nodes larger than 7 cm, hb, platelets, lymphocytes, beta-2-microglobulin, albumin, hcv infection, serum paraprotein and type. annotated follow-up features included date of progression to a disease requiring treatment, type of first line treatment, date of start of first line treatment, date of progression after first line treatment, date of second line treatment, type of second line treatment, date of transformation, date of death, cause of death, date of last follow-up. mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis and dna methylation profile will be performed by next generation sequencing of genomic dna extracted from the lymph node biopsy. gene expression will be assessed by next generation sequencing of rna extracted from the lymph node biopsy.

Eligibility criteria:
inclusion criteria: 1. male or female adults 18 years or older 2. diagnosis of nmzl on lymph node histology after jan 1st, 2000 3. availability of tumor material from lymph node (either frozen or ffpe) collected when the patient was treatment naïve 4. availability of the baseline and follow-up annotations exclusion criteria: 1. nodal spread of a clinically occult extranodal mzl (this must have been ruled out by carefully evaluating the extranodal tissues draining to the involved lymph nodes by imaging or endoscopy)
validation of neurokeeper's algorithm on patients undergoing cardiac surgery.

Conditions: Stroke

Summary: the primary objective of the study is to check the ability of neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery. the secondary objectives is correlations of eeg + erp measurements with clinical evaluations as assessed by nihss this study is a prospective, open label, single arm, self control, single center study. this study will be conducted in 50 subjects according to the inclusions/exclusions criteria.


Eligibility criteria:
inclusion criteria: * age \> 18 years old. * patients undergoing cardiac surgery . exclusion criteria: * previous major hemispheric stroke. * any known major hemispheric lesion. * significant movement disorder. * local skull or skin affliction which prevents electrodes application. * any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Keywords: stroke
effect of two methods of soft tissue augmentation for socket closure on soft tissue landmarks and ridge dimensions

Conditions: Recession, Gingival

Summary: to evaluate the effect of connective tissue graft and pediculated-connective tissue graft for extraction socket closure on soft tissue landmarks and ridge dimensions.

45 subjects were randomized into two groups experimental: main treatment group p-ctg group active comparator: control group ctg group.

Eligibility criteria:
inclusion criteria: * based on the extraction defect sounding(eds) classification given by caplanis et al, 1. systemically healthy subjects within the age group of 20-50years 2. with extraction defect type 2 and type 3 were included in this study exclusion criteria: 1. medically compromised patients 2. subjects who underwent radiotherapy or chemotherapy and 3. smokers
trial of proton pump inhibitor with prokinetics or placebo in patients with laryngopharyngeal reflux disease

Conditions: Laryngopharyngeal Reflux Disease

Summary: based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (lprd) (glicksman et al. 2014), well designed study was performed in 4 articles. but, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. they had similar results that prokinetics and proton pump inhibitor (ppi) had synergistic effect for management of lprd. therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.


Eligibility criteria:
inclusion criteria: * age between 20 and 65 years * reflux symptom index (rsi) \> 7 and, reflux finding score (rfs) \> 13 exclusion criteria * taken proton pump inhibitor within 3months * taken steroid within 3months * pregnancy * breast feeding

Keywords: laryngopharyngeal reflux disease prokinetics proton pump inhibitor
estrogen replacement and atherosclerosis (era) in older women

Conditions: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause

Summary: to determine if estrogen replacement therapy, with or without low dose progesterone, slows progression or induces regression of coronary atherosclerosis in postmenopausal women.

background: cardiovascular disease is the number one cause of death in postmenopausal women. postmenopausal estrogen replacement is associated with a lower incidence of cardiovascular disease in women, especially in those with established coronary artery disease. the strength of the apparent effect of estrogen in epidemiologic studies suggests that estrogen plays a fundamental role in the maintenance of vascular health. animal data suggest that the current practice of adding the low dose progesterone to prevent endometrial hyperplasia may inhibit the beneficial effects of estrogen on coronary arteries. before committing millions of postmenopausal women to long-term estrogen use for prevention of coronary artery disease, it is mandatory to demonstrate that it does indeed protect against coronary atherosclerosis, to determine the impact of co-treatment with progestin, and to understand the mechanisms through which estrogen may exert it's cardioprotective effects. the office of research on women's health provided $500,000 in fiscal year 1995 for recruitment of subjects. design narrative: randomized, placebo-controlled, blinded. the minimum diameter of coronary stenotic lesions was measured by angiography before and after three years in a group receiving unopposed estrogen replacement therapy, a group receiving estrogen replacement plus continuous low dose progestin, and a group receiving placebo. the incidence of clinical events was documented in all three groups. secondary objectives of the trial included examining the effect of chronic and acute estrogen administration on endothelium-dependent coronary vasodilator capacity, plasma lipids and lipoproteins, antioxidant activity, blood pressure, glucose metabolism, and plasma hemostatic factors, as well as on behaviors, physical attributes, and psychosocial parameters. there were four pre-randomization variables in order to pre-stratify. these included current smoking status, insulin dependent diabetes, current lipid-lowering therapy, and the hospital where angiograms were performed. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
postmenopausal women with established coronary atherosclerosis.
characterization of retinal microvascular and faz changes in ischemic stroke and its different types

Conditions: Ischemic Stroke

Summary: the study aimed to access the microvascular changes in the superficial capillary plexus (scp) and deep capillary plexus (dcp) in patients with ischemic stroke and its different types using optical coherence tomography angiography.

investigators used octa to quantitatively access the retinal microvasculature of scp and dcp, aiming to detect the geometry changes of retinal microvasculature and faz in ischemic stroke patients and its different types.

Eligibility criteria:
inclusion criteria: patients who were diagnosed with ischemic stroke by mri were scheduled for an octa examination. the diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the trial of org 10172 in acute stroke treatment (toast). exclusion criteria: 1) retinal diseases or diseases affecting vessel structure in fundus photography, including age-related maculopathy; diabetic retinopathy, central serous chorioretinopathy, retinal pigment epithelial detachment and glaucoma); poor cooperation in ophthalmic examinations; high refractive error (\>+6.00 d or \<-6.00 d spherical equivalent); low-quality octa images (signal strength index \< 6/10). inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.

Keywords: ischemic stroke optical coherence tomography angiography retina